product titer
IRI: https://spec.industrialontologies.org/ontology/construct/ProductTiter
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/
SubClass Of: concentration
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:quality › bfo:relational quality › concentration › product titer
Definition
concentration of a process intermediate material or material product that is determined by the amount of a target product in that process intermediate material or material product per unit volume
Explanatory Notes
1) In this context, ‘target product’ denotes the specified substance of interest for the manufacturing objective and may be a drug substance, process intermediate, or other designated active or functional component. Product titer is evaluated at a specified time point and may vary over time due to dilution, degradation, or changes in process volume. 2) Here, process material means a material that is being transformed or modified in a manufacturing process, including process intermediate material and the material product. It does not include raw materials or consumables.
Examples
- titer of 3.2 g/L monoclonal antibody in a cell culture harvest on day 14; titer of 2.8 g/L monoclonal antibody in a clarified harvest after depth filtration; titer of 12 g/L monoclonal antibody in a protein A eluate after elution;
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs for creating a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
ProductTiter(x) → Concentration(x) ∧ ∃m ((ProcessIntermediateMaterial(m) ∨ MaterialProduct(m)) ∧ qualityOf(x, m))
Semi-Formal Natural Language Axioms
if x is a ‘product titer’ then x is a ‘concentration’ that is the ‘quality of’ some ‘process intermediate material’ or some ‘material product’